NCT00963651

Brief Summary

To perform a multiple reader, multiple case (MRMC) observer study assessing the detection performance of VolumeRAD tomosynthesis of the chest in detecting lung nodules.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 for all trials

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 24, 2013

Status Verified

July 1, 2013

Enrollment Period

3.9 years

First QC Date

August 20, 2009

Last Update Submit

July 23, 2013

Conditions

Pulmonary Nodule, SolitaryMultiple Pulmonary Nodules

Keywords

Pulmonary nodule, solitaryMultiple pulmonary nodules

Outcome Measures

Primary Outcomes (1)

  • Multi-reader, multi-case Receiver Operating Characteristics (ROC) methodology.

    The primary objective of this study is to determine if the use of VolumeRAD tomosynthesis increases the accuracy of the detection of lung nodules between 3mm and 20mm in diameter when compared to conventional PA and lateral chest radiography alone.

    Post accrual of 210 participants

Secondary Outcomes (1)

  • Actionability classification accuracy of all modalities

    Multipe reader, multiple case reader study

Study Arms (1)

Suspicion of pulmonary nodules

Eligible participants will include those referred for x-ray computed tomography (CT) of the chest for suspicion of a pulmonary nodule or other unrelated reasons.

Device: Chest tomosynthesis and X-ray

Interventions

Chest tomosynthesis and X-rayDEVICE

VolumeRAD tomosynthesis; Conventional Chest X-ray; Dual energy (bone and soft tissue PA chest images)

Suspicion of pulmonary nodules

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will include those referred for x-ray computed tomography (CT) of the chest for suspicion of a pulmonary nodule or other unrelated reasons.

You may qualify if:

  • Scheduled for chest CT as part of their needed medical care;
  • If available, individuals who have had previous imaging to suggest they fulfill the needs of the study;
  • years of age, or older;
  • In good enough physical condition to stand motionless and hold their breath during the image acquisition procedures.

You may not qualify if:

  • Children under 18 years of age;
  • Women who are pregnant or who suspect they may be pregnant;
  • Individuals who on previous imaging are shown to have objects in or around the lungs that might produce substantial artifacts that would obscure pulmonary nodules;
  • Individuals who on recent imaging had active lung or pleural disease that would obscure pulmonary nodules;
  • Individuals with more than 5 pulmonary nodules between 5mm and 20mm in diameter in either right or left lung.
  • Individuals suspected to have more than 15 total nodules between 3mm and 20mm. NOTE that up to 20 nodules between 3mm and 20mm will be allowed in the final study sample.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Michigan

Ann Arbor, Michigan, 48103, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Sahlgrenska University Hospital

Gothenburg, SE-413 45, Sweden

Location

MeSH Terms

Conditions

Solitary Pulmonary NoduleMultiple Pulmonary Nodules

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • James Dobbins, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2009

First Posted

August 21, 2009

Study Start

August 1, 2009

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 24, 2013

Record last verified: 2013-07

Locations

US(3)SE(1)